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RSS FeedPosted by Michael Wonder on 17 Feb 2026
FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
17 February 2026 - Johnson & Johnson today announced the US FDA has approved a new, simplified monthly dosing schedule for ...
Posted by Michael Wonder on 13 Feb 2026
Disc Medicine receives complete response letter from FDA for bitopertin for the treatment of EPP
13 February 2026 - Disc Medicine announced that the US FDA today issued a complete response letter for the new drug ...
Posted by Michael Wonder on 13 Feb 2026
Agilent receives FDA approval for PD-L1 IHC 22C3 pharmDx in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
11 February 2026 - Approval expands PD-L1 testing to support treatment decisions with Keytruda (pembrolizumab). ...
Posted by Michael Wonder on 12 Feb 2026
FDA refusing to review Moderna mRNA flu shot application
11 February 2026 - Moderna said on Tuesday that the FDA has refused to review its application for an mRNA flu ...
Posted by Michael Wonder on 12 Feb 2026
Price, therapeutic value impact international submission times for new drugs
11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, ...
Posted by Michael Wonder on 11 Feb 2026
Moderna receives refusal to file letter from the US FDA for its investigational seasonal influenza vaccine, mRNA-1010
10 February 2026 - Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
Posted by Michael Wonder on 10 Feb 2026
FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
10 February 2026 - Today, the FDA approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, ...
Posted by Michael Wonder on 10 Feb 2026
RegenxBio announces regulatory update on RGX-121 BLA for MPS II
9 February 2026 - RegenXBio today announced that the US FDA has issued a complete response letter regarding its biologics ...
Posted by Michael Wonder on 09 Feb 2026
ICER releases evidence report on therapies for IgA nephropathy
9 February 2026 - All three therapies exhibit net health benefits, but uncertainties remain around the magnitude of long-term improvements ...
Posted by Michael Wonder on 08 Feb 2026
FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma
6 February 2026 - FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. ...
Posted by Michael Wonder on 06 Feb 2026
IBSA USA announces FDA approval of Vybrique, the first and only oral film to treat men with erectile dysfunction
5 February 2026 - US commercial availability anticipated in March 2026. ...
Posted by Michael Wonder on 03 Feb 2026
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus
3 February 2026 - The US FDA issued a complete response letter regarding the biologics license application for Saphnelo (anifrolumab) for ...
Posted by Michael Wonder on 02 Feb 2026
Aquestive Therapeutics announces FDA issuance of complete response letter for Anaphylm
2 February 2026 - Deficiencies limited to packaging and administration. ...
Posted by Michael Wonder on 02 Feb 2026
Pharming Group receives complete response letter from US FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS
1 February 2026 - Pharming today announced that the US FDA has issued a complete response letter to its supplemental ...
Posted by Michael Wonder on 29 Jan 2026
Tenpoint Therapeutics announces FDA approval of Yuvezzi, the first and only combination eye drop approved to treat presbyopia
28 January 2026 - Tenpoint Therapeutics today announced that the US FDA approved Yuvezza (carbachol and brimonidine tartrate ophthalmic solution) ...